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Observational Study of Persistence on Bafiertam Treatment In Routine Clinical Practice

Sponsored by Banner Life Sciences LLC

About this trial

Last updated 2 years ago

Study ID

BLS-11-404

Status

Enrolling by invitation

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 months ago

What is this trial about?

This is an open-label, multicenter, observational study of the adherence of patients with relapsing-remitting multiple sclerosis (RRMS) prescribed Bafiertam (monomethyl fumarate) as their treatment.

What are the participation requirements?

Yes

Inclusion Criteria

1. Male or non-pregnant female aged 18 years and older.

2. Participants diagnosed with Relapsing forms of multiple sclerosis R(RMS) and satisfy the approved therapeutic indication for Bafiertam per the approved product labeling.

3. Participants may enroll if they are within 90 days of initiating therapy with Bafiertam.

4. Female participants of childbearing potential must practice effective contraception from Day -1 and be willing and able to continue contraception for the duration of the study.

5. Willing and able to sign the informed consent form (ICF) approved by the Institutional Review Board (IRB).

6. Willing and able to complete all the study procedures and communicate meaningfully with study personnel.

No

Exclusion Criteria

1. Known hypersensitivity to fumarates including dimethyl fumarate, Tecfidera, and/or diroximel fumarate (Vumerity) or Bafiertam.

2. Participated in another clinical trial within 30 days, suffered or still recovering from a medically significant event of surgery within 30 days, or previously participated in a clinical study with a similar investigational product.

Locations

Location

Status